Pharmacovigilance & Regulatory Affairs Consulting in China
PV Solutions Limited provides consulting services to International pharmaceutical companies on pharmacovigilance and regulatory affairs in China.
PV Solutions Limited provides consulting services to International pharmaceutical companies on pharmacovigilance and regulatory affairs in China.
What We Offer
Comprehensive preparation and support for pharmacovigilance inspections and audits in China. We provide documentation review, compliance assessment, inspection readiness preparation, and remote or on-site audits of your local partners.
Mock GCP inspections and audits tailored for overseas sponsors' investigational sites and contract research organizations (CROs) in China. We conduct realistic audit scenarios to identify gaps and ensure readiness for regulatory inspections.
Comprehensive pharmacovigilance strategy and operational frameworks including annual report, QPPV/RPPV designation, PSUR/PBRER, system files and post-market surveillance strategies.
Expert guidance on navigating China's GVP requirements, regulatory submissions, and compliance with NMPA standards. We provide comprehensive support for regulatory intelligence, gap analysis, and product registration.
PV Solutions Limited brings specialized expertise in China's complex pharmacovigilance and regulatory environment including GCP&GVP requirements, GCP inspection, GVP audit, NMPA compliance, data gap assessment. We ensure comprehensive compliance with Chinese regulatory standards and pharmacovigilance requirements throughout your product lifecycle.
Comprehensive audit and assessment services for Good Clinical Practice and Good Vigilance Practice compliance, ensuring alignment with international standards and Chinese regulatory expectations
Expert liaison with NMPA and provincial authorities for PV inspections, audits, and regulatory compliance management
Design and implementation of PV systems including PSMF, QMS and ICSR reporting compliant with Chinese regulatory requirements
Strategic guidance on market entry, product lifecycle management, and long-term regulatory strategy in China's evolving pharmaceutical landscape
Understanding China's NMPA Pharmacovigilance Inspection Structure (Guideline for Drug Pharmacovigilance Inspection - NMPA No. 2022/17)
National Medical Products Administration - Sets inspection standards and assigns inspectors to Drug Inspection Institutions
Provincial Medical Products Administration oversees regional compliance and coordinates with municipalities
Local authorities manage grassroots compliance and apply inspection standards from higher authorities
Designated institutes conducting field inspections and building inspector information platforms
Provides expertise in pharmacovigilance standards and safety monitoring protocols
Institutes for Drug Evaluation, Reevaluation, and Adverse Drug Reaction monitoring
Pharmacovigilance System Master File compliance and documentation
Individual Case Safety Report collection, evaluation, and reporting procedures
Ongoing safety surveillance and periodic safety updates (PSUR)
Qualified inspectors and inspection team designation and conduct
Alignment with GVP and GCP standards in China's regulatory environment
Procedures for managing non-compliant cases and regulatory affairs coordination
PV Solutions Limited help global pharmaceutical companies navigate China's complex regulatory landscape with confidence. Backed by our local experts with decades of combined experience in pharmacovigilance and regulatory affairs, we provide tailored consulting services that enable pharma companies to enter and succeed in the Chinese market.
Our team brings deep expertise in GCP and GVP audit and mock inspections, regulatory intelligence and local compliance coordination. We are committed to supporting our clients' success in the Chinese market through tailored, professional quality consulting services.
We'd love to hear from you. Whether you're planning market entry in China, conducting a mock GCP inspection/GVP audit, or need regulatory guidance, reach out to PV Solutions Limited to discuss your project.
Thank you for reaching out!
We'll be in touch soon.
Something went wrong
Please try again later.